Cleared Traditional

K834523 - MODEL M410D HEARING AID

K834523 is the FDA 510(k) clearance for MODEL M410D HEARING AID by Radioear Corp.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K834523 · Radioear Corp. · Ear, Nose, Throat device
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Feb 1984
Decision
51d
Days
Class 1
Risk

K834523 is an FDA 510(k) clearance for the MODEL M410D HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Radioear Corp. (Mchenry, US). The FDA issued a Cleared decision on February 10, 1984 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3300 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Radioear Corp. devices

Submission Details

510(k) Number K834523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1983
Decision Date February 10, 1984
Days to Decision 51 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 89d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ESD Hearing Aid, Air-conduction, Prescription
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3300
Definition An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ESD Hearing Aid, Air-conduction, Prescription

All 740
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K834523.
BEHIND-THE-EAR HEARING AID 2000
K840871 · Telex Communications, Inc. · Mar 1984
RIONET HEARING AID HB-71M
K841012 · Rion Acoustic Instruments, Inc. · Mar 1984
POST-AURICULAR HEARING AID
K840359 · Phonic Ear, Inc. · Feb 1984
HEARING AID
K833926 · Rion Acoustic Instruments, Inc. · Dec 1983
OTICON, E26P
K833803 · Oticon Corp. · Dec 1983
PERSONAL AMPLIFIER
K832168 · Electone, Inc. · Nov 1983